`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AYLA PHARMA LLC,
`Petitioner
`
`v .
`
`ALCON RESEARCH, LLC,
`Patent Owner.
`
`U.S. Patent No. 9,533,053 to Gamache et al.
`Issue Date: January 3, 2017
`Title: High Concentration Olopatadine Ophthalmic Composition
`
`Inter Partes Review No.: IPR2020-00295
`
`Updated Exhibit List
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Petitioner’s Updated Exhibit List of 6/5/2020
`Exhibit
`Ex #
`1001 U.S. Patent No. 8,791,154 B2 (“’154 Patent”)
`1002 U.S. Patent No. 9,533,053 B2 (“’053 Patent”)
`1003 WO 2008/015695 A2 (“Bhowmick”)
`1004 YANNI et al., “The In Vitro and In Vivo Ocular Pharmacology of
`Olopatadine (AL-4943A), an Effective Anti-Allergic/Antihistaminic
`Agent,” Journal of Ocular Pharmacology and Therapeutics, Volume 12,
`Number 4, 1996, pp. 389-400 (“Yanni”)
`1005 U.S. Pat. No. 6,995,186 B2 (“Castillo”)
`1006 U.S. Pat. Pub. No. 2011/0082145 A1 (“Schneider”)
`1007 U.S. Pat. No. 5,641,805 (“Hayakawa”)
`1008
`File Wrapper for U.S. Patent No. 8,791,154 B2
`1009
`File Wrapper for U.S. Provisional Appl. No. 61/487,789
`1010
`File Wrapper for U.S. Provisional Appl. No. 61/548,957
`1011
`Physician’s Desk Reference - PATANOL®; PATADAY® (“PDR”)
`1012 Handbook of Pharmaceutical Excipients
`David B. Troy, Remington: The Science and Practice of Pharmacy,
`Philadelphia College of Pharmacy and Science, 21st ed., 229, 856-866
`(2005)
`1014 Declaration of Dr. Laskar
`1015
`Argentum Pharm. LLC v. Alcon Research, Ltd., IPR2016-00544,
`Paper 8 (P.T.A.B. July 18, 2016)
`
`1013
`
`Apotex, Inc. v. Alcon Research Ltd., IPR2016-01640, Paper 2
`(P.T.A.B. Aug. 18, 2016)
`
`Alcon Research, Ltd. v. Watson Labs., 1-15-cv-01159 (D. Del.) Paper
`69 (November 18, 2016)
`
`1016
`
`1017
`
`142732136v1
`
`
`
`1018 Abelson & Gomes, “Olopatadine 0.2% ophthalmic solution: the first
`ophthalmic antiallergy agent with once-daily dosing,” Expert Opinion
`on Drug Metabolism & Toxicology, 4:4, 453-461 (2008) (“Abelson”)
`Pharmaceutical Calculations, 13th ed., Ansell, 2010
`
`1019
`
`1020 U.S. Patent No. 6,770,675
`
`1021
`
`1022
`
`1023
`
`1024
`
`Argentum Pharm. LLC v. Alcon Research, Ltd., IPR2016-00544,
`Paper 1 (P.T.A.B. Feb. 2, 2016)
`
`Apotex, Inc. v. Alcon Research Ltd., IPR2016-01640, Paper 3
`(P.T.A.B. Aug. 18, 2016)
`
`Apotex, Inc. v. Alcon Research Ltd., IPR2016-01640, Paper 8
`(P.T.A.B. Oct. 5, 2016)
`
`Apotex, Inc. v. Alcon Research Ltd., IPR2016-01640, Paper 9
`(P.T.A.B. Nov. 30, 2016)
`
`1026
`
`1025 Abelson & Loeffler, Conjunctival Allergen Challenge: Models in the
`Investigation of Ocular Allergy, Current Allergy and Asthma Reports
`3:363-368 (2003)
`Eiichi Uchio, Treatment of allergic conjunctivitis with olopatadine
`hydrochloride eye drops, Clinical Ophthalmology 2(3):525-531, 527-
`528 (2008)
`1027 Abelson et al., “Efficacy of Once-Daily Olopatadine 0.2% Ophthalmic
`Solution Compared to Twice-Daily Olopatadine 0.1% Ophthalmic
`Solution for the Treatment of Ocular Itching Induced by Conjunctival
`Allergen Challenge,” Current Eye Research 32:1017-1022 (2007)
`
`142732136v1
`
`
`
`1028
`
`Leonardi, et al., “The anti-allergic effects of a cromolyn sodium-
`chlorpheniramine combination compared
`to ketotifen
`in
`the
`challenge model,” European
`J. of
`conjunctival allergen
`Ophthalmology 13(2):128-133 (2003)
`
`1029 U.S. Patent Publication No. 2008/0085922
`
`1030
`
`1031
`
`Alcon Research, Ltd. v. Watson Labs., 1-15-cv-01159 (D. Del.) Paper
`155 (March 1, 2018)
`https://www.pazeodrops.com/
`
`1032 Orange Book entry for PAZEO®
`
`1033
`
`EP 0214779
`
`1034 U.S. Pat. No. 4,871,865
`
`1035
`
`EP 0235796
`
`1036 U.S. Pat. No. 5,116,863
`
`1037
`
`CV of Dr. Paul Laskar
`
`1038 Handbook of Chemistry and Physics 2006, 87th ed.
`
`1039 U.S. Publication No. 2004/0198828 (“Abelson”)
`
`1040 Nandi et al., “NANDI et al., “Synergistic Effect of PEG-400 and
`Cyclodextrin
`to Enhance Solubility of Progesterone,” AAPS
`PharmSciTech 2003; 4 (1), pp 1-5.”
`
`142732136v1
`
`
`
`1041
`
`LOFTSSON et al., “Cyclodextrins in eye drop formulations: enhanced
`topical delivery of corticosteroids to the eye,” Acta Ophthamologica
`Scandinavica, 2002, pp. 144-150.
`
`1042 Declaration of Dr. S. Craig Dyar
`
`1043
`
`CV of Dr. S. Craig Dyar
`
`1044
`
`Transcript of Telephone Conference Call 5/28/2020
`
`142732136v1
`
`
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